EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

NCT ID: NCT06657066

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2023-08-08

Brief Summary

The objective of this study is to compare the effectiveness of probiotic as an adjuvant to standard therapy versus standard therapy alone in adult with moderate to severe persistent asthma in terms of

1. Frequency of asthma exacerbations in terms of number of asthma attacks and severity of each episode.

2. Improvement in pulmonary function tests as recorded by an increase in FEV1 and FEV1/FVC ratio.

5. HYPOTHESIS Probiotics as an adjuvant to standard therapy is more effective as compared to the standard therapy alone in managing moderate to severe persistent bronchial asthma.

Detailed Description

Design of Study This was a Randomized controlled trial

Follow up protocol The patient was evaluated at the beginning of the study, and then again at one and three months following enrolment for a follow-up evaluation of the main and secondary outcomes.

Primary outcome To assess the frequency of exacerbations within 3 months.

Secondary outcome:

To observe improvement in

1. FEV1 and the FEV1/FVC ratio. Improvement in one step and more than 12% Improvement in FEV1 from baseline. Improvement in asthma control test. Sample Size - The calculated sample size is 74 individuals (37 in each category i.e Intervention & Control arm)

Sampling technique - Simple random sampling Sample selection Inclusion Criteria

1. Patients of both genders between the ages of 18 and 80 years.

2. Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition.

Exclusion Criteria

1. Patients with Mild asthma.

2. Pregnant females.

3. Patients who have taken fiber supplement or probiotics during the last four weeks.

4. Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer.

5. Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).

Conditions

Asthma Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm - Group A

Standar Therapy- Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram.

Along with Probiotics i.e Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii

Group Type: EXPERIMENTAL

Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii

Intervention Type: DRUG

Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram plus Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii. It was given daily for three months

Control arm- Group B

Standard therapy only:

Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram

Group Type: PLACEBO_COMPARATOR

Control (Standard treatment)

Intervention Type: DRUG

The control arm will receive only standard treatment for asthma i.e Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram.

Interventions

Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii

Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram plus Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii. It was given daily for three months

Intervention Type: DRUG

Control (Standard treatment)

The control arm will receive only standard treatment for asthma i.e Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram.

Intervention Type: DRUG

Other Intervention Names

Group A; Group B

Eligibility Criteria

Inclusion Criteria

1. Patient of both genders between the ages of 18 and 80 years.

2. Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition.

Exclusion Criteria

1. Patients with Mild asthma.

2. Pregnant females.

3. Patients who have taken fiber supplements or probiotics during the last four weeks.

4. Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer.

5. Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

binayak singh

MD (Postgraduate Trainee)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Binayak Singh, MD

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University Lahore

Locations

King Edward Medical University, Neelagumbad, Anarkali, Lahore, Pakistan. Postal Code: 54000 Telephone: +92 (42) 99211145-54

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Related Links

https://immunenetwork.org/DOIx.php?id=10.4110/in.2021.21.e19

Clinical and molecular phenotypes of asthma are complex. The main phenotypes of adult asthma are characterized by eosinophil and/or neutrophil cell dominant airway inflammation that represent distinct clinical features. Upper and lower airways constitute

Other Identifiers

6952/REG/KEMU/22MD200023

Identifier Type: -

Identifier Source: org_study_id